Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2010-06-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MOZOBIL
treatment with mozobil for autologous stem cell collection
Plerixafor
Plerixafor (mozobil) 240 mcg/kg SC will be administered in the evening, 10 hours prior to initiation of apheresis.G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.
Interventions
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Plerixafor
Plerixafor (mozobil) 240 mcg/kg SC will be administered in the evening, 10 hours prior to initiation of apheresis.G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
1.2 WBC count ≥2.5x109/L.
1.3 Absolute neutrophil count ≥1.5x109/L.
1.4 Platelet count ≥100x109/L
1.5 Adequate cardiac, renal, hepatic and pulmonary function sufficient to undergo apheresis and transplantation.
1.6 Previously, heavily pretreated lymphoma patients or patients suspected to have a poor bone marrow stem cell reserve for at least one of the following:
* \>2 lines of chemotherapy.
* Previous radiotherapy involving bone marrow
* Prior therapy with specific stem cell toxic chemotherapeutic agents
* Platelets count pre-mobilisation, ≤150.103 x mm3
* Level of circulating CD34+ ≤ 20 cells/mcL prior to apheresis on the collection day
* Patients \> 60 years of age
2.2 History of any acute or chronic leukemia (including myelodysplastic syndrome.
2.3 Prior allogeneic or autologous transplantation.
2.4 Inability to tolerate stem cell harvest.
2.5 Peripheral venous access not possible.
2.6 Pregnant or nursing women.
2.7 Positive serology for hepatitis B or C.
2.8 Acute infection (febrile, i.e. temperature \> 38C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF.
2.9 HIV positive.
2.10 Left ventricular ejection fraction \< 50%.
2.11 DLCO \< 50%.
2.12 Splenectomised or splenic irradiation.
2.13 Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study.
2.14 Treatment with other investigational drugs within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase.
18 Years
75 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Arnon Nagler, MD
Role: PRINCIPAL_INVESTIGATOR
Chaim Sheba Medical Center
Locations
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Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Countries
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Other Identifiers
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SHEBA-09-7481-AN-CTIL
Identifier Type: -
Identifier Source: org_study_id